HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT
FDA premarket approval P850010/S072 · decided 2016-09-15
Approval details
- PMA number
- P850010
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2016-08-19
- Decision date
- 2016-09-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Replacement of a portion of the water deionization (DI) system, located in the Collagen Manufacturing Center. Integra will replace a portion of the DI system with a new Evoqua IonRight GEN3 system. The change is being made to lower operating expenses, as well as reduce the frequency of service of the system by reducing the frequency at which the vessels are shipped off site for regeneration.
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